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1.52 Source Documents Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial). 1.9 Audit Trail Documentation that allows reconstruction of the course of events. (ICH GCP flj) Quality Management The coordinated activities to direct and control an organization with regard to quality. 1.46 Quality Assurance (QA) All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s). Definition; ICH-GCP: International Conference on Harmonisation-Good Clinical Practice (Food and Drug Administration guideline) 1.42 Opinion (in relation to Independent Ethics Committee) The judgement and/or the advice provided by an Independent Ethics Committee (IEC). The relevant ICH documents are listed in Annex 1. means the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) together with such other good clinical practice requirements as are specified in Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 relating to medicinal products for human use and in guidance published by the European Commission pursuant to such … Essential Documents for the Conduct of a Clinical Trial). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: 1.18 Coordinating Committee A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. Preventive Action is action taken to eliminate the causes of a potential nonconformity, defect, or other undesirable situation in order to prevent occurrence. within the European Community and within the ICH regions. 1.12 Clinical Trial/Study Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. 1.21 Direct Access Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. ich-gcp Clinical studies should be carried out according to International Conference on Harmonisation (ICH) / WHO Good Clinical Practice (GCP) standards. ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports (PDF - 240KB) This International Conference on Harmonization (ICH) document makes recommendations on … 1.34 Investigator A person responsible for the conduct of the clinical trial at a trial site. 1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. 1.33 Investigational Product A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. 1.35 Investigator / Institution An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”. Audit Report A written evaluation by the sponsor’s auditor of the results of the audit. (ISO 9000 [3]) Quality Assurance All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s). The GCP-IWG is of the opinion that the ICH-GCP guideline and applicable EU laws do not prohibit such practice, but it should be clear who has the responsibility for all aspects of subject protection and data reliability and robustness and the procedures in place should ensure that the rights, safety, dignity and well-being of subjects are being protected and the data generated are credible and accurate. GLOSSARY 2. Informed consent is documented by means of a written, signed and dated informed consent form. The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. Medical and scientific judgment should be exercised in deciding whether expedited reporting is These bodies are sometimes referred to as competent authorities. 1 Scope of the Guideline The objective of this Guideline is to outline the mission and the organization of a sponsor’s auditing department and the principles for planning, performing and reporting audits, all of which should be considered when the auditor who belongs to the sponsor performs an audit a clinical trial performed by the sponsor. It replaces the previous 1990 guideline entitled Good Clinical Practice for Trials on Medicinal Products in the European Community (III/3976/88), adopted May 1990. 1.51 Source Data All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results. The terms clinical trial and clinical study are synonymous. 1.8 Audit Report A written evaluation by the sponsor’s auditor of the results of the audit. 1.13 Clinical Trial/Study Report A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports). 1.53 Sponsor An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. 1.14 Comparator (Product) An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. 1.30 Institution (medical) Any public or private entity or agency or medical or dental facility where clinical trials are conducted. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. This provides a unified standard for the European Union (EU), Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organisation (WHO). 1.56 Subinvestigator Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). The Principles of ICH GCP . (ICHGCP [1]) Audit Certificate A declaration of confirmation by the auditor that an audit has taken place. 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